Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02520141

Recruitment Status : Completed

First Posted : August 11, 2015

Results First Posted : June 15, 2023

Last Update Posted : June 15, 2023

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Cholangiocarcinoma Liver and Intrahepatic Bile Duct Carcinoma Stage III Gallbladder Cancer AJCC v7 Stage III Intrahepatic Cholangiocarcinoma AJCC v7 Stage IIIA Gallbladder Cancer AJCC v7 Stage IIIB Gallbladder Cancer AJCC v7 Stage IV Gallbladder Cancer AJCC v7 Stage IVA Gallbladder Cancer AJCC v7 Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7 Stage IVB Gallbladder Cancer AJCC v7 Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7 Unresectable Gallbladder Carcinoma
Interventions	Other: Laboratory Biomarker Analysis Biological: Ramucirumab
Enrollment	61

Participant Flow

Recruitment Details	MD Anderson Cancer Center Houston Tx
Pre-assignment Details


Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Arm/Group Description	Phase II, single-arm trial for adva...
Arm/Group Description	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
Period Title: Overall Study
Started	61
Completed	60
Not Completed	1
Reason Not Completed
Rapid decline clinically and thus unable to enroll	1

Baseline Characteristics

Arm/Group Title		Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Arm/Group Description		Phase II, single-arm trial for adva...
Arm/Group Description		Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
Overall Number of Baseline Participants		60
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	60 participants
		58.5 (41 to 80)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants
	Female	36 60.0%
	Male	24 40.0%
Ethnicity (NIH/OMB) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants
	Hispanic or Latino	0
	Not Hispanic or Latino	0
	Unknown or Not Reported	0
		[1] Measure Analysis Population Description: Race and Ethnicity Not Collected
Race (NIH/OMB) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants
	American Indian or Alaska Native	0
	Asian	0
	Native Hawaiian or Other Pacific Islander	0
	Black or African American	0
	White	0
	More than one race	0
	Unknown or Not Reported	0
		[1] Measure Analysis Population Description: Race and Ethnicity Not Collected
Region of Enrollment ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	0 participants
		[1] Measure Description: Region of Enrollment data not collected [2] Measure Analysis Population Description: Region of Enrollment data not collected

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival of Ramucirumab in Advanced Biliary Cancers
Description	Progression free survival is measured using 95% confidence intervals. ...
Description	Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Arm/Group Description:	Phase II, single-arm trial for adva...
Arm/Group Description:	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
Overall Number of Participants Analyzed	60
Median (95% Confidence Interval) Unit of Measure: months
	3.2 (2.1 to 4.8)

2.Secondary Outcome


Title	Overall Survival (OS)
Description	Overal Survival (OS): the time from treatment initiation to death from...
Description	Overal Survival (OS): the time from treatment initiation to death from any cause. OS functions were estimated using the Kaplan-Meier method .
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Arm/Group Description:	Phase II, single-arm trial for adva...
Arm/Group Description:	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC with ECOG 0/1, adequate liver, renal, and marrow functions
Overall Number of Participants Analyzed	60
Median (95% Confidence Interval) Unit of Measure: Months
	9.5 (5.81 to 13.6)

3.Secondary Outcome


Title	Overall Response Rate (RR)
Description	The proportion of patients with the best overall response of complete ...
Description	The proportion of patients with the best overall response of complete response or partial response (PR)]
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV
Arm/Group Description:	Phase II, single-arm trial for adva...
Arm/Group Description:	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
Overall Number of Participants Analyzed	60
Measure Type: Number Unit of Measure: participants
	1

4.Secondary Outcome


Title	Percentage of Disease Control Rate
Description	Partial Response + Complete Response + Stable Disease (ORR + Stable Di...
Description	Partial Response + Complete Response + Stable Disease (ORR + Stable Disease)
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV
Arm/Group Description:	Phase II, single-arm trial for adva...
Arm/Group Description:	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
Overall Number of Participants Analyzed	60
Measure Type: Number Unit of Measure: percentage
	45

Adverse Events

Time Frame	Up to 6 years
Adverse Event Reporting Description	NCI CTCAE version 4.0.

Arm/Group Title	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Arm/Group Description	Phase II, single-arm trial for adva...
Arm/Group Description	Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
All-Cause Mortality
	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
	Affected / at Risk (%)
Total	60/60 (100.00%)
Serious Adverse Events Serious Adverse Events
	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
	Affected / at Risk (%)	# Events
Total	1/60 (1.67%)
Gastrointestinal disorders
Upper GI Bleeding ^†	1/60 (1.67%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
	Affected / at Risk (%)	# Events
Total	60/60 (100.00%)
Gastrointestinal disorders
Upper GI hemorrhage ^†	1/60 (1.67%)
Nausea and vomiting ^†	16/60 (26.67%)
Abdominal pain ^†	14/60 (23.33%)
Diarrhea ^†	14/60 (23.33%)
Anorexia ^†	12/60 (20.00%)
Constipation ^†	11/60 (18.33%)
Ascites ^†	8/60 (13.33%)
Abdominal distension ^†	4/60 (6.67%)
Mucositis ^†	4/60 (6.67%)
Gastric obstruction ^†	3/60 (5.00%)
Gastroesophageal reﬂux ^†	3/60 (5.00%)
Cholangitis ^†	2/60 (3.33%)
Biliary obstruction ^†	1/60 (1.67%)
Esophagitis ^†	1/60 (1.67%)
Gastroparesis ^†	1/60 (1.67%)
Hiccups ^†	1/60 (1.67%)
General disorders
Fatigue ^†	23/60 (38.33%)
Fever ^†	11/60 (18.33%)
Diaphoresis ^†	4/60 (6.67%)
Dehydration ^†	3/60 (5.00%)
Chills ^†	2/60 (3.33%)
Hot ﬂashes ^†	2/60 (3.33%)
Pruritus ^†	2/60 (3.33%)
Facial edema ^†	1/60 (1.67%)
Immune system disorders
Allergic rhinitis ^†	4/60 (6.67%)
Infections and infestations
Sepsis ^†	4/60 (6.67%)
Investigations
Proteinuria ^†	23/60 (38.33%)
Thrombocytopenia ^†	13/60 (21.67%)
Anemia ^†	11/60 (18.33%)
Hyperbilirubinemia ^†	9/60 (15.00%)
Alkaline phosphatase increase ^†	9/60 (15.00%)
AST increase ^†	9/60 (15.00%)
Hyponatremia ^†	9/60 (15.00%)
ALT increase ^†	8/60 (13.33%)
Hyperkalemia ^†	7/60 (11.67%)
Hypercalcemia ^†	5/60 (8.33%)
Hypomagnesemia ^†	5/60 (8.33%)
Creatinine ^†	4/60 (6.67%)
Hypoalbuminemia ^†	3/60 (5.00%)
Hematuria ^†	2/60 (3.33%)
Hypermagnesemia ^†	2/60 (3.33%)
Hypoglycemia ^†	2/60 (3.33%)
Hypokalemia ^†	2/60 (3.33%)
Prolonged PTT ^†	1/60 (1.67%)
Hyperglycemia ^†	1/60 (1.67%)
Hypocalcemia ^†	1/60 (1.67%)
Hypophosphatemia ^†	1/60 (1.67%)
Hypotension ^†	1/60 (1.67%)
Increased INR ^†	1/60 (1.67%)
Musculoskeletal and connective tissue disorders
Back pain ^†	6/60 (10.00%)
Neck pain ^†	2/60 (3.33%)
Nervous system disorders
Headache ^†	21/60 (35.00%)
Dizziness ^†	9/60 (15.00%)
Extremity pain ^†	7/60 (11.67%)
Neuropathy ^†	5/60 (8.33%)
Confusion ^†	3/60 (5.00%)
Blurry vision ^†	1/60 (1.67%)
Delirium ^†	1/60 (1.67%)
Renal and urinary disorders
Urinary tract infection ^†	6/60 (10.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^†	7/60 (11.67%)
Cough ^†	5/60 (8.33%)
Chest pain ^†	4/60 (6.67%)
Pneumonitis ^†	2/60 (3.33%)
Skin and subcutaneous tissue disorders
Dry skin ^†	6/60 (10.00%)
Skin rash ^†	3/60 (5.00%)
Vascular disorders
Hypertension ^†	25/60 (41.67%)
Pulmonary embolism ^†	1/60 (1.67%)
Lower extremity edema ^†	13/60 (21.67%)
Thrombocytopenic purpura ^†	2/60 (3.33%)
Epistaxis ^†	1/60 (1.67%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Milind Javle
Organization:	M D Anderson Cancer Center
Phone:	(713) 792-5434
EMail:	mjavle@mdanderson.org

Layout table for additonal information

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT02520141
Other Study ID Numbers:	2015-0393 NCI-2015-01442 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2015-0393 ( Other Identifier: M D Anderson Cancer Center )
First Submitted:	August 5, 2015
First Posted:	August 11, 2015
Results First Submitted:	April 24, 2023
Results First Posted:	June 15, 2023
Last Update Posted:	June 15, 2023

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